Biostatistican II, Oncology (Office/Home-Based) - IQVIA Biotech (R1040101) in Morrisville, NC bei IQVIA™

Datum der Veröffentlichung 7/3/2019


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Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.


Provide statistical expertise and leadership to project and analysis team.  Provide statistical consulting and technical support as it relates to the design and statistical analysis of clinical studies.  Determine analysis and data presentation specifications for SAS Programming staff.  Perform analysis, interpret study results, and collaborate with medical and biostatistics staff to produce interim reports and final reports.  May be responsible for more than one study.


  • Collaborates with program staff on the implementation and analysis of statistical aspects of research protocols.
  • Provides statistical consultation for clinical programs, including but not limited to protocol development, randomization, sample size assessments, efficacy evaluations, and data review.
  • Provides input to project timelines, and ensures that project timelines for biostatistics deliverables are met for both internal and external clients.
  • Ensures that project tasks are completed with acceptable quality for both internal and external clients.
  • Coordinates with SAS programming staff to ensure the accurate programming of SAS clinical data extracts and data displays.
  • Develops statistical analysis summary and analysis plans, including textual description of planned analysis and mock-ups of data displays.
  • Reviews and provides comments on statistical summaries and analysis plans.
  • Develops programming specifications to summarize the results of clinical trials, including analysis datasets and tables/listings/figures.
  • Performs statistical analyses, including hypothesis testing and modeling.
  • Provides tabular and written summaries of analyses and statistical methodology for Clinical Study Reports.
  • Consults with sponsors regarding development of statistical analysis plans, protocol content and study design as dictated by the specific nature of the project.
  • Interacts with Medical Writers to ensure appropriateness of data inferences.
  • Writes pertinent sections of a clinical study report
  • Interfaces with clients and/or regulatory agencies as the project biostatistician.
  • Attends team meetings and represent departmental needs for assigned projects.


  • Understanding of GCP, ICH, and FDA guidelines and regulations applicable to conduct clinical research.
  • Experience with, and mastery of, statistical methods commonly used in the analysis of data obtained from Phase I – IV clinical trials.
  • Experience with SAS Base and SAS Stat, as well as strong data step skills.
  • Experience with other statistical software packages, such as N-Query, S-Plus.
  • Ability to work creatively and independently to carry out assignments of a complex nature.
  • Ability to work effectively and cooperatively with other professional staff members.
  • Ability to communicate effectively, both verbally and in writing, with all levels of staff and with the public.


  • Very limited physical effort required to perform normal job duties.


Degree requirements include one of the following:

  • Masters-level degree in Statistics, Biostatistics or related field with four years relevant work experience; total work experience to include one year in CRO industry or biotech;  or
  • Doctorate-level degree in Statistics, Biostatistics or related field with one year relevant work experience in CRO industry or biotech. 
  • Data handling and analysis experience. 
  • Excellent interpersonal and organization skills. 

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled'

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™

Job ID: R1040101